Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2025-12-28 @ 12:17 PM
Study NCT ID:
NCT05840861
Status:
UNKNOWN
Last Update Posted:
2023-08-14
First Post:
2023-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using 18F-FPEB PET to Identify mGLUR5 Availability in Affective Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078784', 'term': 'Vortioxetine'}, {'id': 'D000069348', 'term': 'Quetiapine Fumarate'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003987', 'term': 'Dibenzothiazepines'}, {'id': 'D013841', 'term': 'Thiazepines'}, {'id': 'D013846', 'term': 'Thiepins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 59}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-09-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-08', 'studyFirstSubmitDate': '2023-04-23', 'studyFirstSubmitQcDate': '2023-04-23', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline concentration of mGLUR5 availability', 'timeFrame': 'Day 0', 'description': 'BPND at baseline as measured by PET'}, {'measure': 'Change in concentration of mGLUR5 availability from baseline to 8 weeks', 'timeFrame': 'Week 8', 'description': 'BPND changes from baseline to 8 weeks'}, {'measure': 'Change of Hamilton Depression Rating Scale-17 (HAMD-17) score from baseline to 8 weeks', 'timeFrame': 'Week 8', 'description': 'Change of Hamilton Depression Rating Scale-17 (HAMD-17) score from baseline to 8 weeks, range: 0-51, higher score means more severe symptom of depression'}, {'measure': 'Clinical outcome: Number of Participants with remitters and non-remitters', 'timeFrame': 'Week 8', 'description': 'Remitters: Hamilton Depression Rating Scale (HAMD-17)≤7, non-remitters: Hamilton Depression Rating Scale (HAMD-17)≥8'}, {'measure': 'functional-connectivity', 'timeFrame': 'baseline and week8', 'description': 'functional-connectivity from functional-MRI'}, {'measure': 'neurite density', 'timeFrame': 'baseline and week8', 'description': 'neurite density from Neurite Orientation Dispersion and Density Imaging (NODDI)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Major Depressive Disorder', 'Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'Evidence suggests that mGLUR5 availability may play a key role in the biology of mood disorders. This study aimed to investigate the changes in metabotropic glutamate receptor 5 (mGLUR5) availability and clinical symptoms in patients with MDD and bipolar disorder(BD) after two months of vortioxetine treatment. The investigators hypothesized that patients with MDD and BP have abnormal mGluR5 availability in certain brain regions, and baseline mGLUR5 availability can predict prognosis the prognosis of MDD and BD. fMRI and NODDI are also used to evaluate the function or neurite condition at baseline and 8 week'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '15 healthy controls, 22 MDD patients, 22 BD patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet DSM-V criteria for a current depressive episode.\n* Being first-episode patients who were medication-naïve;\n* Score \\>17 on 17-item Hamilton Depression Rating Scale (HDRS), score \\>22 on Montgomery-Asberg Depression Rating Scale (MADRS), and score \\<6 on Young Mania Rating Scale (YMRS).\n* Age 18 to 35.\n* Able to give written informed consent.\n\nExclusion Criteria:\n\n* Have a current or past significant medical, neurological or metabolic disorder or head injury\n* Have active, significant suicidal ideation or past suicide attempts\n* Have implanted metallic devices or any MR contraindications\n* Are women who are pregnant or breastfeeding\n* Met DSM-5 criteria for substance use disorder\n* Met DSM-5 criteria for any current Axis I diagnosis (except Generalized Anxiety Disorder)\n* Are MDD patients present with delusions and/or hallucinations'}, 'identificationModule': {'nctId': 'NCT05840861', 'briefTitle': 'Using 18F-FPEB PET to Identify mGLUR5 Availability in Affective Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Central South University'}, 'officialTitle': 'Using 18F-FPEB PET to Identify mGLUR5 Availability in Affective Disorders', 'orgStudyIdInfo': {'id': 'PCT 202007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MDD', 'description': 'Participants with major depressive disorder (MDD), unmedicated and currently depressed to participate in MRI and \\[18F\\]FPEB PET scans', 'interventionNames': ['Drug: Vortioxetine']}, {'label': 'Bipolar', 'description': 'Participants with bipolar disorder, unmedicated and currently depressed to participate in MRI and \\[18F\\]FPEB PET scans', 'interventionNames': ['Drug: Quetiapine']}, {'label': 'Healthy Control', 'description': 'Healthy participant with no MDD or other psychiatric condition to participate in MRI and \\[18F\\]FPEB PET scans'}], 'interventions': [{'name': 'Vortioxetine', 'type': 'DRUG', 'description': 'All MDD patients will receive 5mg of Vortioxetine per day at the start of this study, which will be gradually increased to 10mg per day within one week.', 'armGroupLabels': ['MDD']}, {'name': 'Quetiapine', 'type': 'DRUG', 'description': 'All patients with bipolar disorder will receive 50mg of Quetiapine at day 1, 100mg of Quetiapine at day 2, 200mg of Quetiapine at day 3, and 400mg of Quetiapine per day since day 4.', 'armGroupLabels': ['Bipolar']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410001', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Zhang, MD PhD', 'role': 'CONTACT'}], 'facility': 'Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Yan Zhang, MD PhD', 'role': 'CONTACT', 'email': 'yan.zhang@csu.edu.cn', 'phone': '13807315182'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhang Yan', 'investigatorAffiliation': 'Central South University'}}}}